Survey results: Would Metabolite’s claim 13 be found patentable under the reasoning of Bilski?

Earlier in the week, I wrote about Bilski in relation to the recent diagnosis patent case of LabCorp v. Metabolite. Metabolite’s claim 13 reads as follows:

13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

I asked the following question to Patently-O readers and received a response from about 200 readers: It reads as follows:

Would Metabolite’s claim 13 be found patentable under the reasoning of Bilski?

The response can be broken down as follows: 31% of responses would find the claim to include patentable subject matter while the remaining 69% would reject the claim under Section 101. Of those who would find the claim patentable, the vast majority (89%) reason that the claim includes a transformation. In my discussion of the case, I indicated one argument for showing how the assay step could be considered a transformation. The remaining 11% of those who would find the claim patentable say that it is tied to a particular machine or apparatus. None of the responses indicated that the claim satisfied both the machine and transformation prongs of the test.

Of the 69% of “unpatentable” responses, the majority (72%) saw the claim unpatentable as neither a machine nor a transformation. 43% of those asserting unpatentability saw the claim as unpatentable under the revived mental steps doctrine of bilski. Included in these figures is the 16% who saw the patent violating both the revived mental steps doctrine and the machine-or-transformation test.

The survey did not ask demographic data. However, of those responses using a USPTO IP address, 86% would find the claim unpatentable under Section 101.

28 thoughts on “Survey results: Would Metabolite’s claim 13 be found patentable under the reasoning of Bilski?

  1. 28

    If anyone knows of a way of “assaying a body fluid for an elevated level of total homocysteine” without using a machine, I’d sure like to hear it…

    …or are those who claim it’s unpatentable under Bilski saying that simply including a non-statutory step (“correlating”) along with statutory steps makes the whole claim non-statutory?

  2. 27

    If you are asking whether I think it there is a difference between a doctor correlating elevated homocysteine to folate deficiency and Ted Bundy, I think you know the answer.

    My point is an evidentiary one. Someone asked earlier, “how do you prove infringement by thinking?” The answer I am proposing is that you can’t; the only way is to find circumstantial evidence of the mental process.

    This has interesting consequences for the preemptive footprint of these claims. On one hand, all those frantically searching for Big Brother can remove their foil hats and cross patentees off their list–no one will be dragged into court for simply thinking of something. Damages will further limit the preemptive footprint since no one will sue some guy tinkering with his own blood to determine if he has folate deficiency. On the other hand, the narrowing of the preemptive footprint is minimal since any communication of or action based on the result or correlation can trigger infringement liability. My guess is Breyerites will not let that happen.

  3. 26

    “Proving infringement will, much like any specific intent crime or tort,”

    Do you see any important distinctions between “mental infringement” of a patent and a specific intent to commit a crime or harm another person?

  4. 25

    I haven’t yet seen a satisfactory solution to my Paymentech split infringement problem under the proposed communicating/diagnosing/prescribing claims (even assuming Breyer doesn’t balk at the clear preemption problem).

    I don’t really see any problem with making mental activities infringing activities. It is, after all, “intellectual property.” :) Proving infringement will, much like any specific intent crime or tort, be proved by circumstantial evidence (such as communicating/diagnosing/recording/prescribing). In fact, this is the only way I see out of the Paymentech problem: communicating/diagnosing/recording/prescribing is required as proof of infringement, but is not a step in the claim so that a single entity (e.g., a doctor or a reference lab) practices all steps.

    Bilski MUST be overturned or at least limited in scope (however that might be accomplished).

  5. 24

    question “Malcolm, if the “patient” is a dog (a warm blooded animal) does your “communicating” step make the claim patentable?”

    That’s an interesting question that raises a few related issues. I think the answer is, unsurprisingly, “it depends.” The step of communicating should be defined in the specification as conveying the information to a third party (i.e., a patient, a guardian of a patient, a technician) in a position to take prophylactic, therapeutic or additional diagnostic steps based on the information. “Communicating” in these sorts of claims isn’t satisfied merely by yelling the diagnosis down a hole or whispering it into an empty bottle of scotch.

  6. 23

    “Why wouldn’t a claim that includes a step or steps, where proteins in a sample are transformed (using a machine) to a signal that is useful as a diagnostic measure – be patentable subject matter under Bilski?”

    I think someone has finally proffered an implementation of a fundamental principle that would pass the machine or transformation test.

  7. 22

    Why wouldn’t a claim that includes a step or steps, where proteins in a sample are transformed (using a machine) to a signal that is useful as a diagnostic measure – be patentable subject matter under Bilski?

  8. 21

    What if the claim read as follows:

    A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
    placing a sample of body fluid in a specimen container;
    pouring the specimen container into an analyzing apparatus;
    determining, by the analyzing apparatus, a concentration level of total homocysteine;
    outputting the concentration level; and
    correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.”

    I think that you have simply created multiple data gathering steps in an attempt to claim a machine or transformation. I’m pretty sure that this is still unpatentable under Bilski (bc the only machine or transformation that you claim is found within a data gathering step).

  9. 20

    Idiots… Communicating doesn’t change anything except communicating that Mooney is more of a m0r0n than ever.

  10. 19

    Cashman,

    Sooo … think about this:
    You’re feeling unwell and you go to the doctor, figuring she is going to order some blood tests, do some poking and prodding of your body parts, etc. But when you get there, she pulls out a crystal ball and stares into it to conjure up the answer as to what ails you.

    “Aren’t you going to perform some *scientific* tests,” you ask, “like sampling my vital bodily fluids and assaying them?”

    “No silly Billy,” she answers, “Remember, it’s a THINKING STEP! I do my best thinking simply by staring into this crystal ball. Science is unnecessary.”

  11. 18

    Remember, it’s a THINKING STEP! Assay this, THINK “does this correlate with one of the diseases?” I don’t see how that is patentable subject matter even on cases prior to Bilski.

    It was just the wrong case to bring to the Supreme Court because the issue of patentability was not brought up in the lower courts, but sua sponte.

  12. 17

    Assuming all respondents have read Bilski and are attempting to follow it, it’s rather startling that nearly one-third of respondents come to a different conclusion on the basic issue of patentability of a claim. Perhaps Bilski won’t settle as much as the CAFC hoped.

  13. 16

    Malcolm, if the “patient” is a dog (a warm blooded animal) does your “communicating” step make the claim patentable?

  14. 15

    6000 “I’m still not rock solid on how you tell what an insignificant post-solution activity is.”

    Here is the test I floated in the immediate wake of Bilski: you compare what is achieved by the claimed method when the claimed method includes the additional “post-solution” step versus what is *necessarily* achieved by the claimed method without that step. The asterixed term is important to preclude the tendency to “read into” the claim limitations that aren’t there.

    So you can see how a doctor communicating a result and diagnosis to a patient achieves far more than the doctor merely looking at a result and thinking about it. That’s why communicating is “significant.” Very very very very significant, in fact.

  15. 14

    “But, for the sake of argument, let’s assume that communication of the diagnosis to the patient is required to make the claim pass the 101 hurdle. Why should the court not simply read that limitation from the specification into the claim in order to save it from being invalidated? ”

    Well, in the case of Metabolite they didn’t do it because, as I recall, Metabolite admitted that the scope of the claim included thinking about the correlation.

    And that’s what happens a lot of the time. Entity A has a patent describing diagnosis of disease D by looking at gene G, “wherein mutation M in gene G is correlated with D”. Then Entity A learns that Entity B is making money (or getting ready to make money) by selling an assay for detecting muatation M for some other reason only tangentially related to disease D. Forthermore, Entity A knows for a fact that Entity B is aware of their patent and the correlation disclosed in the patent. If Entity B offers Entity a license and Entity A tells them to dry up and blow away, should Entity B hold off sueing? They should hold off. Because the moment they start asserting that their patent scope includes ****thinking**** about their correlation, then their patent is toast.

    But of course people assert patents all the time knowing that the accused infringer isn’t actually infringing. That’s just how the game is played.

    As for the general practice of “reading stuff into claims,” I respectfully refer you to Phillips and the legion other CAFC cases that teach us how to construe claims. Application and claim drafting is for grown-ups. There is no truth to the claim that “nobody could have predicted” that a claim such as claim 13 would present enforcement problems, particularly if it was asserted to cover the activities alleged by Metabolite. Breyer didn’t pull his dissent out of the trapdoor in the back of his robe.

  16. 13

    I’d like to hear from one of the 11% who think the claimed method is tied to a particular machine. What’s the argument for that?

    That 11% serves merely to show how dumb some people are, they don’t have a “reasoning”.

    “It’s fairly clear that Breyer and Stevens would “see through” such a limitation to identify what was really invented.”

    Insignificant post-solution activity anyone? I’ll be quite honest, I didn’t understand wtf that was until this example came up. Maybe I have it wrong, I’m still not rock solid on how you tell what an insignificant post-solution activity is.

  17. 12

    “The new and non-obvious part of the claim does not have to be the part that is patentable subject matter under 101.”

    What does Comiskey say about that?

  18. 11

    “I’m not sure why anyone believes such a limitation would save the claim. I certainly don’t. It’s fairly clear that Breyer and Stevens would “see through” such a limitation to identify what was really invented.”

    Ah, but that is a slipper slope indeed. Because truly the scientists at Metabolite did not “invent” anything. Rather, they “discovered” something. Are Breyer and Stevens going to attempt to distinguish the two activities and risk blowing the entire enterprise up?

    I doubt it. Why bother? Biotech patents aren’t ruining the system, especially not after ESTs got the axe a few years back (did you hear us biotech types complaining about how biotech innovation would die if that happened? no you didnt). Breyer and Stevens know what the problem is, as sure as the CAFC and the PTO know.

  19. 10

    “Ding ding ding!!!!!!!!!!!!!!”

    I don’t get what you are trying to say. I’m noty at all convinced that the limitation of communicating the diagnosis to the patient is needed for patentability. Performance of the assay was patentable. The correlation is new and non-obvious. The new and non-obvious part of the claim does not have to be the part that is patentable subject matter under 101. Performance of the assay is not post solution activity ala Flook. Performance of the assay is essential to the solution. It seems to me that anyone who thinks the Metabolite claim 13 is not patentable subject matter under 101 must think that the original assay was not patentable subject matter. In any case, they are wrong.

    But, for the sake of argument, let’s assume that communication of the diagnosis to the patient is required to make the claim pass the 101 hurdle. Why should the court not simply read that limitation from the specification into the claim in order to save it from being invalidated? It does not really change the scope of the claim for enforcement purposes. The mental activity of making the correlation, alone, is not a detectable infringement. So why the “ding, ding ding?” I don’t understand what you are trying to say.

  20. 9

    “If the claim had a limitation of communicating the diagnosis to the patient, Metabolite would have still been able to sue LabCorp.”

    I’m not sure why anyone believes such a limitation would save the claim. I certainly don’t. It’s fairly clear that Breyer and Stevens would “see through” such a limitation to identify what was really invented.

  21. 8

    “If the claim had a limitation of communicating the diagnosis to the patient, Metabolite would have still been able to sue LabCorp.”

    Ding ding ding!!!!!!!!!!!!!!

  22. 7

    “Really? You should have mentioned to something to Metabolite when they sued LabCorp. Patentees get very greedy, especially when they’ve got nothing to lose.”

    LabCorp deserved to get sued. Metabolite discovered a new, valuable, surprising use for an old assay and patented it. If the claim had a limitation of communicating the diagnosis to the patient, Metabolite would have still been able to sue LabCorp. Why is the Metabolite claim as issued so bad? What difference does it really make?

  23. 6

    What if the claim read as follows:

    A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
    placing a sample of body fluid in a specimen container;
    pouring the specimen container into an analyzing apparatus;
    determining, by the analyzing apparatus, a concentration level of total homocysteine;
    outputting the concentration level; and
    correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

  24. 5

    “This whole business about infringing claims just by thinking about the correlation seems silly to me.”

    Really? You should have mentioned to something to Metabolite when they sued LabCorp. Patentees get very greedy, especially when they’ve got nothing to lose.

  25. 4

    I’d like to hear from one of the 11% who think the claimed method is tied to a particular machine. What’s the argument for that?

  26. 3

    I don’t see why we can’t just have a rule that the claim, if found to fail 101 at trial, shall have read thereinto a suitable limitation rendering it patentable under 101, said limitation to be read upon the accused infringing product, if possible.

    This whole business about infringing claims just by thinking about the correlation seems silly to me. How would the patent holder even detect infringement? I don’t see what the harm is to allow the metabolite claim to issue and then read in the limitation at trial of communicating the diagnosis to the patient, if necessary.

    Cheating patent holders out of their claims after the fact on these types of technicalities smacks of dirty pool. How were they to foresee the issue 10 or 15 years in advance, especially when reasonable people can easily disagree over the proper outcomes?

  27. 2

    “how would one amend the claim to make it 101 patentable?”

    *sigh*

    Maybe try reading the other threads on the subject where the answer is discussed at length.

    Remember what the Supremes wanted to know when they granted cert? : “Whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to ‘correlat[e]’ test results can validly claim a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent ******merely by thinking****** about the relationship after ******looking****** at a test result.”

    If the method had included a step of communicating the diagnosis to the patient, we wouldn’t be having this discussion. It matters.

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